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  October 17, 2003

FDA and CDC Statement Concerning Rumors About Recalled Lot of Influenza Vaccine

Rumors have been circulating that a "contaminated" lot of flu vaccine has been recalled by the FDA. This is false. No contamination of any flu vaccine has been identified anywhere in the U.S., and the FDA has not recalled any lot of flu vaccine.

Flu vaccine is routinely tested for safety, purity, and potency and all lots released have met these standards. As with any vaccine, flu vaccine is capable of causing some side effects, these are very rarely severe. Most side effects from flu vaccine are mild, such as arm soreness, redness or swelling where the shot was given, fever, or achiness. More serious reactions to the flu vaccine do occur, but they are rare.

While FDA and CDC are currently investigating several recent reports of possible significant allergic reactions to flu vaccine, it is important to note that the number and type of reactions reported to date are not unexpected. The reactions reported, not all of which may have been caused by the administration of vaccine, do not, at this time, suggest any problem with the flu vaccine. However, FDA and CDC will continue to investigate these and any other reports and will provide any further information as available. While serious reactions to flu vaccine are rare, each year about 114,000 people in the U.S. are hospitalized and about 36,000 people die because of the flu.

The flu vaccine is the best way a person can protect themselves and their loved ones against influenza. October and November are the best months to get vaccinated - however, vaccination in December or later still provides considerable protection.

For more information about influenza, go to

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CDC protects people's health and safety by preventing and controlling diseases and injuries; enhances health decisions by providing credible information on critical health issues; and promotes healthy living through strong partnerships with local, national, and international organizations.


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This page last updated October 17, 2003

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